| CTRI Number |
CTRI/2025/07/091068 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing the result of blood product with or without antibiotics in the treatment of gum disease. |
|
Scientific Title of Study
|
"A Comparative Evaluation of Injectable Platelet-Rich Fibrin (i-PRF) With and Without Amoxicillin in the Treatment of Chronic Periodontitis: A Randomized Controlled Trial" |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Yadav |
| Designation |
Academic junior resident |
| Affiliation |
faculty of dental sciences IMS, BHU |
| Address |
Room no 5, 3rd floor, department of periodontology,faculty of dental sciences,trauma centre, BHU varansasi, uttar pradesh
Room no 5, 3rd floor, department of periodontology,faculty of dental sciences,trauma centre, BHU varansasi, uttar pradesh
pin code 221005
Gorakhpur
UTTAR PRADESH
273209
India |
| Phone |
09935473940 |
| Fax |
|
| Email |
yadavpriyanka70299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anju Gautam |
| Designation |
Professor |
| Affiliation |
faculty of dental sciences IMS, BHU |
| Address |
Room no 5, 3rd floor, department of periodontology,faculty of dental sciences,trauma centre, BHU varansasi, uttar pradesh
pin code 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8299867542 |
| Fax |
|
| Email |
dranjugautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Yadav |
| Designation |
Academic junior resident |
| Affiliation |
Faculty of dental sciences IMS, BHU |
| Address |
Room no 5, 3rd floor, department of periodontology,faculty of dental sciences,trauma centre, BHU varansasi, uttar pradesh
Room no 5, 3rd floor, department of periodontology,faculty of dental sciences,trauma centre, BHU varansasi, uttar pradesh
pin code 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09935473940 |
| Fax |
|
| Email |
yadavpriyanka70299@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology, faculty of dental sciences, IMS, BHU, varanasi , uttar pradesh, India, pin code 221005 |
|
|
Primary Sponsor
|
| Name |
Priyanka yadav |
| Address |
nagarjuna girls hostel, BHU campus, varanasi, Uttar pradesh. India ,pin code 221005 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PRIYANKA YADAV |
Faculty of dental sciences IMS, BHU |
Room no 5, 3rd floor, department of periodontology, faculty of dental sciences, trauma centre BHU, Varanasi, pin 221005
Varanasi
UTTAR PRADESH |
09935473940
yadavpriyanka70299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IMS, BHU varanasi uttar pradesh, 221005 india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amoxicillin-Loaded Injectable Platelet-Rich Fibrin (i-PRF) |
900 µL of i-PRF will be mixed with 100 µL of freshly prepared amoxicillin solution (stock concentration: 5 mg/mL) to achieve a final concentration of 0.5 mg/mL. This amoxicillin-incorporated i-PRF will be then transferred into sterile 1 mL insulin syringes (30G).
The prepared mixture is then injected locally into each selected periodontal pocket (with more than 5 mm probing depth), with 0.2 mL deposited subgingivally and an additional 0.1 mL injected intramucosal at the papillary region. |
| Comparator Agent |
Injectable platelet rich fibrin |
10 mL of autologous venous blood will be drawn from each participant under aseptic conditions into sterile, non-coated vacuum tubes (without anticoagulants). The blood sample will be then centrifuged using a horizontal centrifuge at 700 rpm for 3 minutes, following the low-speed centrifugation concept (LSCC). The upper fluid layer containing i-PRF is carefully aspirated within 60 seconds to maintain its liquid phase.
The i-PRF is then loaded into sterile 1 mL syringes and injected subgingivally (approximately 0.2 mL per pocket) into periodontal pockets with depths more than 5 mm, and 0.1 mL will be injected into each adjacent interdental papilla. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with chronic periodontitis o Patients having periodontal pockets of more than 5 mm
2. Patient with clinical attachment loss more than 2 mm
3.Age group between 25- 50 years.
4. Patients with good general health, without any history of systemic disease or under medication
5. Patient ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patient. o Patient on antimicrobial therapy
2. Smokers and smokeless tobacco users.
3. Patients showing unacceptable oral hygiene during evaluation.
4. Patient who received periodontal therapy in the past 6 months.
5.Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of amoxicillin incorporated I-PRF as local drug delivery for the treatment. |
At base line, 1month, 3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
I.Assessment of gingival index and plaque index before and after placement of amoxicillin incorporated I-PRF as local drug delivery.
II.Assessment of periodontal pocket depth (PPD) and clinical attachment index (CAL) before and after index before and after placement of amoxicillin incorporate I-PRF .
III.To compare the effect of amoxicillin incorporated I-PRF with I-PRF alone as Local drug Delivery.
|
At base line,1week,3week, 1month, 3month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To achieve the desirable accomplishments, there we are attempting to evaluate the clinical efficacy of injectable Platelet-Rich Fibrin (i-PRF) with and without amoxicillin as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis. A total of eligible participants will be randomly allocated into two groups: the test group will receive SRP followed by subgingival injection of amoxicillin-loaded i-PRF, while the control group will receive SRP followed by injection of drug-free i-PRF. i-PRF is prepared from autologous blood using a low-speed centrifugation protocol and injected into periodontal pockets more than 5 mm and adjacent interdental papillae in a single treatment session. The study aims to assess and compare clinical periodontal parameters such as probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) at baseline and subsequent follow-ups. The objective is to determine whether the addition of amoxicillin to i-PRF enhances periodontal healing outcomes compared to i-PRF alone. |